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  Ami Lifesciences Pvt. Ltd.
an UGMP Certified Company
   
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Quality Assurance and Regulatory Affairs

 
Quality Control & Assurance
 
Quality is the most important Attribute and the Key Differentiator for AMI Group, committed to the Total Quality Management System conforming the National and the International regulations.

We have the requisite Infrastructure and expertise to ensure proper regulatory approvals of our clients and competent authorities such as USFDA, TGA, KFDA, UKMHRA, EDQM, ANVISA etc.
 
QA department ensures that all activities associated with the design, development and manufacturing (Prchase, Warehouse, Production, Quality Control, Release and Distribution) of Active Pharmaceutical Ingredients and Intermediates are carried out in a systematic and approved manner in the compliance with the regulatory and the Good Manufacturing Practices (cGMP) reqyurenebts.
 
Implementation of the Quality System, monitoring the well defined process controls and documentation procedures are the key features of the AMI Group's Quality Assurance and Regulatory Affairs department which ensures the quality product, meeting all the pre-determined specifications consistently.
 
WHO cGMP ISO OHSAS EMS EDQM
Certificate Cetificate 18001 : 1999 14001 : 2004 Certificate
 
 

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